Progression-free Survival After Minimally Invasive Surgical Microwave Ablation Plus Durvalumab (MEDI4736) and Tremelimumab for Unresectable Non-metastatic Locally Advanced Pancreatic Cancer: MIMIPAC Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Baki Topal
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase-2 monocenter non-randomized prospective clinical trial evaluates the effectiveness of minimally invasive microwave ablation plus immunotherapy for unresectable non-metastatic locally advanced pancreatic cancer.
详细描述
Research Hypothesis Does MIS-MWA combined with durvalumab (MEDI4736) plus tremelimumab and gemcitabine prolong progression-free survival in patients with unresectable non-metastatic adenocarcinoma of the pancreas?
Investigational Product(s) and Reference Therapy:
Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.
Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.
Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with unresectable non-metastatic Locally Advanced Pancreatic Cancer (LAPC) defined according to NCCN guidelines Version 2.2017
- •Histologically proven adenocarcinoma of the pancreas located in the head, body or tail
- •LAPC tumor greatest diameter maximum 5 cm
- •Male or female, age 18 years and older, ECOG PS 0-1
- •Life expectancy of at least 12 weeks
- •Only patients who did not receive chemotherapy for their PC are allowed
- •Patients without distant organ metastases on conventional diagnostic imaging
- •Pre-operative biliary drainage for obstructive jaundice is allowed, but the type of biliary stent is standardized in all jaundiced patients
- •Patients fit for MIS-MWA
- •Able to receive Durvalumab and Tremelimumab.
- •Patients with good liver and renal function and with good hematology
- •Effective contraception for both male and female patients if applicable. Women of childbearing potential must have negative blood pregnancy test at screening visit.
- •Written informed consent (+ optional for TR) must be given according to ICH/GCP and national/European regulations
排除标准
- •Pregnancy
- •Metastatic PC on conventional diagnostic imaging or staging laparoscopy
- •LAPC tumor greatest diameter is larger than 5 cm
- •Borderline or resectable PC defined according to the NCCN guidelines version 2.2017
- •Systemic chemo(radio)therapy is not allowed before MIS-MWA
- •Major surgical procedure within 28 days prior to the first dose of investigational products
- •Classic contraindications for PDL and CTLA antibodies
研究组 & 干预措施
MIMIPAC
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
干预措施: Durvalumab 50 MG/ML (Drug)
MIMIPAC
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
干预措施: Tremelimumab (Drug)
MIMIPAC
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
干预措施: Gemcitabine (Drug)
MIMIPAC
Intervention: MIS-MWA plus immunotherapy using the combination of durvalumab with tremelimumab
干预措施: Minimally Invasive Surgical Microwave Ablation (MIS-MWA) (Procedure)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 12 months
The study is exploratory and cannot be statistically powered for comparisons. Median progression-free survival (PFS) time is chosen as the clinically meaningful outcome. Survival estimates will be calculated using the Kaplan-Meier method. For information, the reference PFS time in patients with non-metastatic LAPC treated with gemcitabine monotherapy is about 6 months. Results will be presented descriptively.
次要结局
未报告次要终点
研究者
Baki Topal
Professor, Doctor
University Hospital, Gasthuisberg